- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03423134
Investigating the Performance of a New Adhesive Strip
January 31, 2019 updated by: Coloplast A/S
A Pilot Evaluation of Newly Developed Adhesives and How They Are Impacted by Out-put
This study investigates the performance of a new adhesive
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Humlebæk, Denmark, 3050
- Coloplast A/S
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Have had a stoma for more than one year
- Have intact skin on the area used in the evaluation
- Has a stoma with a diameter up to (≤) 35 mm
- Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)
Exclusion Criteria:
- Currently receiving or have within the past 2 month received radio- and/or chemotherapy
- Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
- Are pregnant or breastfeeding
- Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
- Actively participating in other interventional clinical investigations or have previously participated in this investigation.
5.1. Exception: Participation in other Coloplast in-house clinical investigations are accepted under the circumstances of otherwise complying with the Inclusion and exclusion criteria of this protocol (CP265)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test of new adhesive strip
A new adhesive strip will be tested in this investigation
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This is a strip made of a newly developed adhesive
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
trans epidermal water loss
Time Frame: 24 hours
|
The trans epidermal water loss is a measure for the skins barrier function.
There is always a loss of water from the skin due to evaporation.
When the skin barrier is damaged the evaporation of water increases.
Thus, trans epidermal water loss can be used to assess skin damage
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24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lene F Nielsen, Head of the pre-clinical department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 25, 2018
Primary Completion (Actual)
February 20, 2018
Study Completion (Actual)
February 20, 2018
Study Registration Dates
First Submitted
January 31, 2018
First Submitted That Met QC Criteria
January 31, 2018
First Posted (Actual)
February 6, 2018
Study Record Updates
Last Update Posted (Actual)
February 1, 2019
Last Update Submitted That Met QC Criteria
January 31, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CP265_19
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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